I. PREAMBLE · PRADEEP SRIVASTAVA~ MD~ AND PRADEEP SRIVASTAVA, PC I. PREAMBLE Pradeep Srivastava,...

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INTEGRITY AGREEMENT BETWEEN THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES AND PRADEEP SRIVASTAVA~ MD~ AND PRADEEP SRIVASTAVA, PC I. PREAMBLE Pradeep Srivastava, MD, and Pradeep Srivastava, PC (collectively, "Srivastava") hereby enter into this Integrity Agreement (Agreement) with the Offce of Inspector General (OIG) of the United States Department of Health and Human Services (HHS) to promote compliance with the statutes, regulations, program requirements, and written directives of Medicare, Medicaid, all other Federal health care programs (as defined in 42 D.S.C. § 1320a-7b(f)), and the Federal Employees Health Benefits Program (FEHBP) (collectively, "Federal health care program requirements"). This Agreement applies to any entity that Srivastava owns or in which Srivastava has a control interest, as defined in 42 U.S.C. § 1320a-3(a)(3), and Srivastava's and any such entity's Covered Persons as defined in Section II.C. Contemporaneously with this Agreement, Srivastava is entering into a Settlement Agreement with the United States, and this Agreement is incorporated by reference into the Settlement Agreement. II. TERM OF THE AGREEMENT A. The date on which the final signatory of this Agreement executes this Agreement shall be known as the Effective Date. The period of compliance obligations assumed by Srivastava under this Agreement shall be five years from the Effective Date of this Agreement. Each one-year period, beginning with the one-year period following the Effective Date, shall be referred to as a "Reporting Period." B. Sections VII, VIII, ix, X, and XI shall expire no later than 120 days from OIG's receipt of: (1) Srivastava's final Annual Report; or (2) any additional materials submitted by Srivastava pursuant to OIG's request, whichever is later. C. The scope of this Agreement shall be governed by the following definitions: 1. "Covered Persons" includes: Srivastava Integrity Agreement

Transcript of I. PREAMBLE · PRADEEP SRIVASTAVA~ MD~ AND PRADEEP SRIVASTAVA, PC I. PREAMBLE Pradeep Srivastava,...

Page 1: I. PREAMBLE · PRADEEP SRIVASTAVA~ MD~ AND PRADEEP SRIVASTAVA, PC I. PREAMBLE Pradeep Srivastava, MD, and Pradeep Srivastava, PC (collectively, "Srivastava") hereby enter into this

INTEGRITY AGREEMENTBETWEEN THE

OFFICE OF INSPECTOR GENERALOF THE

DEPARTMENT OF HEALTH AND HUMAN SERVICES

AND

PRADEEP SRIVASTAVA~ MD~ AND PRADEEP SRIVASTAVA, PC

I. PREAMBLE

Pradeep Srivastava, MD, and Pradeep Srivastava, PC (collectively, "Srivastava") herebyenter into this Integrity Agreement (Agreement) with the Offce of Inspector General(OIG) of the United States Department of Health and Human Services (HHS) topromote compliance with the statutes, regulations, program requirements, and writtendirectives of Medicare, Medicaid, all other Federal health care programs (as defined in42 D.S.C. § 1320a-7b(f)), and the Federal Employees Health Benefits Program(FEHBP) (collectively, "Federal health care program requirements"). This Agreementapplies to any entity that Srivastava owns or in which Srivastava has a control interest,as defined in 42 U.S.C. § 1320a-3(a)(3), and Srivastava's and any such entity's CoveredPersons as defined in Section II.C. Contemporaneously with this Agreement,Srivastava is entering into a Settlement Agreement with the United States, and thisAgreement is incorporated by reference into the Settlement Agreement.

II. TERM OF THE AGREEMENT

A. The date on which the final signatory of this Agreement executes this Agreementshall be known as the Effective Date. The period of compliance obligations assumed bySrivastava under this Agreement shall be five years from the Effective Date of thisAgreement. Each one-year period, beginning with the one-year period following theEffective Date, shall be referred to as a "Reporting Period."

B. Sections VII, VIII, ix, X, and XI shall expire no later than 120 days from OIG'sreceipt of: (1) Srivastava's final Annual Report; or (2) any additional materialssubmitted by Srivastava pursuant to OIG's request, whichever is later.

C. The scope of this Agreement shall be governed by the following definitions:

1. "Covered Persons" includes:

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a. all owners, offcers, directors, associates, and employees of Srivastava;and

b. all contractors, agents, and other persons who provide patient careitems or services or who perform biling or coding functions on behalf ofSrivastava.

2. "Relevant Covered Persons" includes Covered Persons involved in thedelivery of patient care items or services and/or in the preparation or submissionof claims for reimbursement from any Federal health care program.

III. INTEGRITY OBLIGATIONS

Srivastava shall establish and maintain a Compliance Program that includes thefollowing elements:

A. Compliance Contact

Within 30 days after the Effective Date, Srivastava shall designate an employeeother than himself to be responsible for compliance activities (ComplianceContact). Srivastava shall maintain a Compliance Contact for the term of thisAgreement. The Compliance Contact shall be responsible for: (1) developingand implementing policies, procedures, and practices designed to ensurecompliance with the requirements set forth in this Agreement and with Federalhealth care program requirements; (2) monitoring Srivastava's day-to-daycompliance activities; and (3) meeting all reporting obligations created under thisAgreement.

Srivastava shall report to 010, in writing, any changes in the identity or jobresponsibilities of the Compliance Contact, or any actions or changes that wouldaffect the Compliance Contact's ability to perform the duties necessary to meetthe obligations in this Agreement, within 15 days after such change. The name,address, phone number, and a description of any other job responsibiltiesperformed by the Compliance Contact shall be included in the ImplementationReport.

B. Posting: of Notice

Within the 90 days after the Effective Date, Srivastava shall post in a prominent

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place accessible to all patients and Covered Persons a notice detailing hiscommitment to comply with all Federal health care program requirements in theconduct of his business.

This notice shall include the following information: (i) a means (~, telephonenumber or address) by which biling concerns and other issues may be reportedanonymously; (ii) Srivastava's commitment to maintain the confidentiality of thereport; and (iii) notification that reporting concerns and issues wil not result inretribution or retaliation by Srivastava.

This notice shall also include the HHS OIO Fraud Hotline telephone number (l-800-HHS- TIPS) as a confidential means by which suspected fraud or abuse inthe Federal health care programs may be reported.

A copy of this notice shall be included in the Implementation Report.

C. Independent Coding Offcer

1. Within 60 days after the effective date of this CIA, Srivastava shall retain anappropriately qualified Independent Coding Offcer (ICO), appointed by the010 after consultation with Srivastava. The ICO shall have expertise in therules governing submissions of claims to Federal health care programs andFEHBP for cardiology items and services. (The ICO may retain additionalpersonnel, including but not limited to consultants, if needed to help meet theICO's obligations under this CIA.) The ICO may be removed solely at thediscretion of the OIG. If the ICO resigns or is removed by the OIG for anyreason prior to the termination of the CIA, Srivastava shall retain another1CO appointed by the OIG, with the same functions and authorities.

2. Srivastava shall be responsible for all costs reasonably incurred by the ICO incarring out the responsibilities specified in this CIA, including, but notlimited to, travel costs, consultants, administrative personnel, offce spaceand equipment, or additional personneL. Failure to pay the ICO within 30calendar days of submission of his or her invoices for services previouslyrendered shall constitute a breach of the CIA and shall subject Srivastava toone or more of the remedies set forth in Section X infra.

3. The ICO shall have the sole authority and responsibility to develop policies,procedures, and guidelines for submission of claims to Federal health careprograms and FEHBP for Srivastava's services and to determine which

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claims for reimbursement for items and services furnished by Srivastava wilbe submitted to Federal health care programs and FEHBP. Srivastava shallbil Federal health care programs and FEHBP for items and services solely inaccordance with the ICO's policies, procedures, and guidelines. Srivastavashall not participate in the ICO's development of these policies, procedures,and guidelines; his sole role will be to imp1em~nt the policies, procedures,and guidelines developed by the ICO.

4. The ICO shall also be responsible for monitoring the day-to-day activitiesengaged in by Srivastava to implement the ICO's policies, procedures, andguidelines. As part of that monitoring, the ICO shall at least twice per year(and more frequently as he or she sees fit) conduct audits of Srivastava'scompliance with the coding policies, procedures, and guidelines. Within 30days after completion of each such audit, the ICO shall submit to Srivastavaand the OIG a written report of his or her findings and recommendations. Inthe event an ICO audit detects that a claim submitted to a Federal health careprogram was at variance with the ICO's coding policies and procedures, theICO shall investigate the discrepancy and require withdrawal of the claim orrefund of payment as appropriate. Srivastava shall comply with the ICO'sfindings and implement the ICO's recommendations. The ICO shall keepdocumentation of his or her investigations for submission as part of theAnnual Report. The ICO may confer and correspond with the OIG on an exparte basis.

5. To facilitate performance of the ICO's responsibilities, Srivastava shall givethe ICO:

a. immediate access to Srivastava's facilities, at any time and withoutprior notice, to assess compliance with this CIA;

b. prompt access to any of Srivastava's documents and data requested bythe ICO to perform the duties required under this CIA; and

c. prompt access to Srivastava's staff for interviews outside the presenceof supervisory staff or counsel, provided such interviews are conducted inaccordance with all applicable laws and the rights of such individuals.

D. Written Policies and Procedures

Within 60 days after the Effective Date, Srivastava shall develop, implement,

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and distribute written Policies and Procedures to all Covered Persons. Inaddition, Srivastava shall make the promotion of, and adherence to, the writtenPolicies and Procedures an element in evaluating the performance of allemployees. The written Policies and Procedures shall, at a minimum, set forth:

1. Srivastava's commitment to full compliance with all Federal healthcare program and FEHBP requirements, including its commitment toprepare and submit accurate claims consistent with such requirements;

2. the expectation that all of Srivastava's Covered Persons shall beexpected to comply with all Federal health care program and FEHBPrequirements and with Srivastava's own written Policies and Proceduresas implemented pursuant to this Section IIID (including the requirementsof this Agreement);

3. the responsibilty and requirement that all Covered Persons report

suspected violations of any Federal health care program or FEHBPrequirements, or of Srivastava's own Policies and Procedures, to theCompliance Contact and Srivastava's commitment to maintainconfidentiality and anonymity, as appropriate, and not to retaliate withrespect to such disclosures;

4. the possible consequences to both Srivastava and Covered Persons offailure to comply with all Federal health care program and FEHBPrequirements or with Srivastava's written Policies and Procedures and thefailure to report such noncompliance;

5. Srivastava's commitment to remain current with all Federal health careprogram and FEHBP requirements by obtaining and reviewing programmemoranda, newsletters, and any other correspondence from the carrierrelated to Federal health care program and FEHBP requirements;

6. the proper procedures for the accurate preparation and submission ofclaims in accordance with Federal health care program and FEHBPrequirements;

7. the proper documentation of services and billng information;

8. the impropriety of biling CPT 93526 for a combined right and leftheart catheterization when the physician has not performed a complete

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right heart catheterization and has not advanced the catheter into thepulmonary artery for the purpose of taking certain heart pressures andmeasurements;

9. the impropriety of biling CPT code 36200 (introduction of catheter,aorta) in addition to biling for CPT codes 93526 (combined left andright heart catheterization), 93510 (left heart catheterization),9350 1 (right heart catheterization), or 93503 (insertion and placementof flow directed catheterization (Swan-Ganz catheter) for monitoringpurposes);

10. the impropriety of biling CPT codes 37202 (transcatheter therapy,infusion other than for thrombolysis) in addition to billng for acardiac catheterization, angioplasty, stent placement, or 93503(Insertion and placement of flow directed catheterization (Swan-Ganzcatheter) for monitoring purposes);

11. the impropriety of biling CPT code 75896 (trans catheter therapy,infusion, any method, radiological supervision and interpretation) inaddition to biling for a cardiac catheterization, angiop1asty, stent

placement, or insertion of a catheter for monitoring purposes;

12. the impropriety of billng separate CPT codes for the five subparts ofthe percutaneous tranluminal coronar angioplasty (PTCA) procedureinstead of biling the component CPT Code 92982 (PTCA);

13. the impropriety of biling separate CPT codes for the sevencomponents ofthe pacemaker implantation procedure instead ofbiling the applicable component CPT codes 33200, 22306, 33207,33208, or 33210;

14. the impropriety of biling for angioplasty (CPT Code 92982) inaddition to biling for a stent (CPT Code 92980) of the same vessel;

15. the impropriety of billng the CPT codes applicable to consultationswhen one is not the physician performing the consultation;

I 6. the impropriety of biling CPT codes applicable to consultations whenthere was no documented request for a consultation;

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17. the impropriety of billng CPT codes applicable to consultations whenthe consulting physician has not submitted a written report of his orher findings to the referring physician;

18. the impropriety of biling CPT codes applicable to consultations whenthe biling physician is actually the patient's treating physician; and

19. the requirement to provide supporting medical documentation whensubmitting a bil for a procedure using a modifier, including but not

limited to the following: modifier 79 (unrelated procedure or serviceby the same physician during the post-operative period); modifier 25

(significant, separately identifiable E&M service by the samephysician on the same day of a procedure or other service); modifier51 (used to describe multiple procedures performed on the same day orat the same session); modifier 59 (indicates that a procedure or servicewas distinct or independent from other services performed on the sameday).

Within 60 days after the Effective Date, each Covered Person shall certify inwriting that he or she has received, read, understood, and shall abide bySrivastava~s written Policies and Procedures. New Covered Persons shallreceive and review the written Policies and Procedures and shall complete therequired certification within 30 .days after becoming a Covered Person or within90 days after the Effective Date, whichever is later.

At least annually, and,more frequently if appropriate, Srivastava shall assess andupdate, as necessary, the Policies and Procedures. Within 30 days after theeffective date of any revisions, the relevant portions of any such revised Policiesand Procedures shall be distributed to all Covered Persons. Appropriate andknowledgeable staff shall be available to explain the Policies and Procedures.

Copies of the written Policies and Procedures shall be included in theImplementation Report. Copies of any written Policies and Procedures that aresubsequently revised shall be included in the next Annual Report along with asummary of any change or amendment to each Policy and Procedure required bythis Section and the reason for each change.

D. Training: and Certification

1. General Training. Within 60 days after the Effective Date, Srivastava shall

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provide at least two hours of General Training to each Covered Person.This training, at a minimum, shall cover the following topics:

a. the requirements of Srivastava's Agreement;

b. an overview of Srivastava's compliance program; and

c. the written Policies and Procedures developed pursuant to SectionIII.D, above.

New Covered Persons shall receive the Oenera1 Training described above within30 days after becoming a Covered Person or within 90 days after the EffectiveDate, whichever is later. After receiving the initial General Training, describedabove, each Covered Person shall receive at least one hour of General Trainingin each subsequent Reporting Period.

2. Specific Training. Within 60 days after the Effective Date, each Relevant

Covered Person shall receive at least two hours of Specific Training in"additionto the Oeneral Training required above. The Specific Training shall be providedby an individual or entity other than Srivastava or another Cov~red Person, andmay be received from a variety of sources (~, CME classes, hospitals,associations, Medicare contractors).

This specific training shall include a discussion of:

a. the accurate coding and submission of claims for services renderedand/or items provided to services and/or the preparation or submission ofclaims for reimbursement from any Federal health care program andFEHBP beneficiaries;

b. policies, procedures, and other requirements applicable to thedocumentation of medical records;

c. the personal obligation of each individual involved in the coding andclaims submission process to ensure that such claims are accurate;

d. applicable reimbursement statutes, regulations, and programrequirements and directives;

e. the legal sanctions for the submission of improper claims or violations

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of the Federal health care program and FEHBP requirements; and

f. examples of proper and improper claim submission practices.

Relevant Covered Persons shall receive this training within 30 days after thebeginning of their employment or becoming a Relevant Covered Person, orwithin 90 days after the Effective Date, whichever is later. A Srivastavaemployee who has completed the Specific Training shall review a new RelevantCovered Person's work, to the extent that the work relates to the delivery ofpatient care items or services and/or the preparation or submission of claims forreimbursement from any Federal health care program or FEHBP, until such timeas the new Relevant Covered Person completes his or her Specific Training.

After receiving the initial Specific Training, each Relevant Covered Person shallreceive at least one hour of Specific Training in each subsequent ReportingPeriod. The Compliance Contact shall annually review the training, and whereappropriate, update the training to reflect changes in Federal health care programand FEHBP requirements, any issues discovered during Claims Reviews and anyother relevant information.

3. Certification. Each individual who is required to receive training shall certifyin writing, or in electronic form if the training is computerized, that he or she hasreceived the required training. The certification shall specify the tye of trainingreceived and the date received. The Compliance Contact shall retain thecertifications along with all training materials. The training materials shall beprovided in the Implementation Report, and to the extent the training is revised,shall also be included in the Annual Reports. The certifications shall be madeavailable to OIG, upon request.

4. Qualifications ofTrainer(s). Persons providing the training shall have

expertise in the subject area. Persons providing Specific Training shall haveparticular expertise in the reinibursement statutes, regulations, and programrequirements and directives applicable to biling Federal health care programsand FEHBP for cardiology items and services.

5. Update of Training. Srivastava shall annually review the training, and, whereappropriate, update the training to reflect changes in Federal health care programand FEHBP requirements, any issues discovered during the Claims Review, anyICO audit or review, or recommendation, and any other relevant information.

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6. Computer Based Training. Srivastava may provide the training requiredunder this Agreement through appropriate computer-based training approaches.If Srivastava chooses to provide computer-based training, he shall makeavailable appropriately qualified and knowledgeable staff or trainers to answerquestions or provide additional information to the individuals receiving suchtraining.

E. Review Procedures

1. General Description.

a. Engagement of Independent Review Organization. Within 60 daysafter the Effective Date, Srivastava shall engage an entity (or entities),(hereinafter "Independent Review Organization" or "IRO"), to performreviews to assist Srivastava in assessing and evaluating his biling andcoding practices, the medical necessity and appropriateness ofinterventiona1 cardiac procedures, and certain other obligations pursuantto this Agreement and the Settlement Agreement. The applicablerequirements relating to the IRO are outlined in Appendix A to thisAgreement, which is incorporated by reference.

Each IRO shall assess, along with Srivastava, whether it can perform theIRO review in a professionally independent and objective fashion, asappropriate to the nature ofthe engagement; taking into account any otherbusiness relationships or other engagements that may exist.

The IRO(s) review shall evaluate and analyze Srivastava's coding, billing,and claims submission to the Federal health care programs and FEHBPand the reimbursement received ("Claims Review"). If Srivastava or anentity in which Srivastava has an ownership or control interest (as definedin 42 U.S.C. § i 320a-3(a)(3)) submits cost reports, Srivastava shall engagean IRO to analyze whether Srivastava sought payment for certainunallowable costs ("Unallowable Cost Review"). The applicablerequirements relating to the IRO are outlined in Appendix A to thisAgreement, which is incorporated by reference.

b. Frequency of IRO Reviews. The IRO Reviews shall be performedannually and shall cover each of the Reporting Periods~ The IRO(s) shallperform all components of each annual IRO Review.

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c. Retention of Records. The IRO and Srivastava shall retain and makeavailable to 010, upon request, all work papers, supportingdocumentation, correspondence, and draft reports (those exchangedbetween the IRO and Srivastava) related to the reviews.

2. Claims Review. The Claims Review shall include a Discovery Sample and, ifnecessary, a Full Sample. The applicable definitions, procedures, and reportingrequirements are outlined in Appendix B to this Agreement, which isincorporated by reference.

a. Discovery Sample. The IRO shall randomly select and review asample of 50 Medicare and 50 FEHBP Paid Claims submitted by or onbehalf of Srivastava (Discovery Sample).

The Paid Claims shall. be reviewed based on the supportingdocumentation available at Srivastava's office or under Srivastava'scontrol and applicable biling and coding regulations and guidance to

determine whether the claim submitted was correctly coded, submitted,and reimbursed.

i. If the Error Rate (as defined in Appendix B) for the DiscoverySample is less than 5%, no additional sampling is required, nor isthe Systems Review required. (Note: The guidelines listed abovedò not imply that this is an acceptable error rate. Accordingly,Srivastava should, as appropriate, further analyze any errorsidentified in the Discovery Sample. Srivastava recognizes thatOIG or other HHS component, in its discretion and as authorizedby statute, regulation, or other appropriate authority may alsoanalyze or review Paid Claims included, or errors identified, in theDiscovery Sample or any other segment of the universe.)

ii. If the Discovery Sample indicates that the Error Rate is 5% orgreater, the IRO shall perform a Full Sample and a SystemsReview, as described below.

b. Full Sample. Ifnecessary, as determined by procedures set fort inSection III.E.2.a, the IRO shall perform an additional sample of PaidClaims using commonly accepted sampling methods and in accordancewith Appendix B. The Full Sample shall be designed to: (i) estimate theactual Overpayment in the population with a 90% confidence level and

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with a maximum relative precision of25% of the point estimate; and (ii)conform to the Centers for Medicare and.Medicaid Services' statisticalsampling for overpayment estimation guidelines. The Paid Claims shallbe reviewed based on supporting documentation available at Srivastava'soffce or under Srivastava's control and applicable billng and codingregulations and guidance to determine whether the claim submitted wascorrectly coded, submitted, and reimbursed. For purposes.of calculatingthe size of the Full Sample, the Discovery Sample may serve as the probesample, if statistically appropriate. Additionally, Srivastava may use theItems sampled as part of the Discovery Sample, and the correspondingfindings for those 50 Items, as part of its Full Sample, if: (i) statisticallyappropriate and (ii) Srivaslava selects the Full Sample Items using theseed number generated by the Discovery Sample. OIG, in its solediscretion, may refer the findings of the Full Sample (and any relatedworkpapers) received from Srivastava to the appropriate Federal healthcare program and FEHBP payor, including the Medicare contractor ~carrier, fiscal intermediary, or DMERC), for appropriate follow-up by thatpayor.

c. Systems Review. If Srivastava's Discovery Sample identifies an ErrorRate of 5% or greater, Srivastava's IRO shall also conduct a SystemsReview. Specifically, for each claim in the Discovery Sample and FullSample that resulted in an Overpayment, the IRO shall perform a "walkthrough" of the system(s) and process(es) that generated the claim toidentify any problems or weaknesses that may have resulted in theidentified Overpayments. The IRO shall provide its observations andrecommendations on suggested improvements to the system(s) and theprocess( es) that generated the claim.

d. Repayment of Identifed Overpayments. In accordance with SectionIII.H.l, Srivastava shall repay within 30 days any Overpayment(s)identified in the Discovery Sample or the Full Sample (if applicable),regardless of the Error Rate, to the appropriate payor and in accordancewith payor refund policies. Srivastava shall make available to OIG anyand all documentation and the associated documentation that reflects therefund of the Overpayment(s) to the payor.

e. Claims Review Report. The IRO shall prepare a report based upon theClaims Review performed (Claims Review Report). Information to beincluded in the Claims Review Report is described in Attachment 1 to

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Appendix B.

3. Cardiac Procedures Review. The IRO shall randomly select and review asample of 50 interventiona1 cardiac procedures performed by Srivastava. TheIRO shall review the interventional cardiac procedures for appropriateness ofcase selection, quality of procedure, execution, proper response to intra-procedural problems, accurate assessment of procedure outcome, andappropriateness of procedure management. The procedures shall be reviewedbased on the supporting documentation available from Srivastava or underSrivastava's control and applicable regulations and guidance to determinewhether the procedure was medically necessary and appropriate, including butnot limited to the established practice guidelines and generally acceptedstandards practice described by the American College of Cardiology. TheCardiac Procedures Review shall be performed annually and shall cover each ofthe Reporting Periods. The IRO engaged by Srivastava shall have expertise inthe medical necessity and appropriateness of interventional cardiac proceduresand in the general requirements of the Federal health care programs andFEHBPfrom which Srivastava seeks reimbursement. The IRO shall prepare a reportbased upon the Cardiac Procedures Review performed (Cardiac ProceduresReview Report). Information to be included in the Cardiac Procedures ReviewReport is described in Appendix B.

4. Validation Review. In the event OIG has reason to believe that:(a) Srivastava's Claims Review or Cardiac Procedures Review fails to conformto the requirements of this Agreement; or (b) the IRO's findings or ClaimsReview or Cardiac Procedures Review results are inaccurate, OIG may, at itssole discretion, conduct its own review to determine whether the Claims Reviewor Cardiac Procedures Review complied with the requirements of the Agreementand/or the findings or Claims Review or Cardiac Procedures Review results areinaccurate ("Validation Review"). Srivastava shall pay for the reasonable cost ofany such review performed by OIG or any of its designated agents so long as it isinitiated within one year after Srivastava's final submission (as described inSection II) is received by OIG.

Prior to initiating a Validation Review, OIG shall notify Srivastava of its intentto do so and provide a written explanation of why OIG believes such a review isnecessary. To resolve any concerns raised by oro, Srivastava may request a

meeting with OIG to: (a) discuss the results of any Claims Review or CardiacProcedures Review submissions or findings; (b) present any additional orrelevant information to clarify the results of the Claims Review or Cardiac

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Procedures Review to correct the inaccuracy of the Claims Review; and/or (c)propose alternatives to the proposed Validation Review. Srivastava agrees toprovide any additional information requested by OIG under this Section in anexpedited manner. OIG will attempt in good faith to resolve any Claims Reviewor Cardiac Procedures Review issues with Srivastava prior to conducting aValidation Review. However, the final determination as to whether or not toproceed with a Validation Review shall be made at the sole discretion ofOIG.

6. Independence/Obiectivity Certification. The IRO shall include in its report(s)to Srivastava a certification or sworn affdavit that it has evaluated itsprofessional independence and objectivity, as appropriate to the nature of theengagement, with regard to the Claims Review and Cardiac Procedures Reviewand that it has concluded that it is, in fact, independent and objective.

F. Ineligible Persons

1. Definitions. For purposes of this Agreement:

a. An "Ineligible Person" shall include an individual or entity who: (i) iscurrently excluded, debarred, suspended, or otherwise ineligible toparticipate in the Federal health care programs or in Federalprocurement or nonprocurement programs; or (ii) has been convictedof a criminal offense that falls within the ambit of 42 U.S.C. § 1320a-7(a), but has not yet been excluded, debarred, suspended, or otherwisedeclared ineligible.

b. "Exclusion Lists" include: (i) the HHS/OIO List of ExcludedIndividua1sÆntities (available through the Internet athttp://oig.hhs.gov);and(ii)theOeneralServicesAdministration'sListof Parties Excluded from Federal Programs (available through theInternet at http://epls.amet.gov)

c. "Screened Persons" include prospective and current owners, offcers,directors, associates, employees, contractors, and agents of Srivastava.

2. Screening Requirements. Srivastava shall ensure that all Screened Personsare not Ineligible Persons, by implementing the following screeningrequirements.

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a. Srivastava shall screen all Screened Persons against the Exclusion Listsprior to engaging their services and, as part of the hiring or contractingprocess, shall require. Screened Persons to disclose whether they areIneligible Persons.

b. Srivastava shall screen all Screened Persons against the ExclusionLists within 90 days after the Effective Date and on an annual basisthereafter.

c. Srivastava shall implement a policy requiring all Screened Persons todisclose immediately any debarment, exclusion, suspension, or other eventthat makes that person an Ineligible Person.

Srivastava shall maintain documentation demonstrating that: (1) he has checkedthe Exclusion Lists ~ print screens from search results) and determined that

such individuals or entities are not Ineligible Persons; and (2) has requiredindividuals and entities to disclose if they are an Ineligible Person (~,employment applications).

Nothing in this Section affects the responsibilty or liabilty of Srivastava torefrain from biling Federal health care programs and FEHBP for services of theIneligible Person.

3. Removal Requirement. If Srivastava has notice that a Screened Person hasbecome an Ineligible Person, Srivastava shall remove such Screened Person fromresponsibility for, or involvement with, Srivastava's business operations relatedto the Federal health care programs and FEHBP and shall remove such ScreenedPerson from anYposition for which the Screened Person's compensation or theitems or services rendered, ordered, or prescribed by the Screened Person arepaid in whole or par, directly or indirectly, by Federal health care programs orotherwise with Federal funds at least unti such time as the Screened Person isreinstated into participation in the Federal health care programs.

4. Pending Charges and Proposed Exclusions. If Srivastava has notice that aScreened Person is charged with a criminal offense that falls within the ambit of42 U.S.C. § 1320a-7(a), or a Screened Person is proposed for exclusion duringhis, her or its employment, involvement or contract term, Srivastava shall take allappropriate actions to ensure that the responsibilities ofthat Screened Personhave not and shall not adversely affect the quality of care rendered to anybeneficiary, patient, or resident, or the accuracy of any claims submitted to any

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Federal health. care program or FEHBP.

G. Notification of Government Investig:ation or Leg:al Proceeding:s

Within 30 days after discovery, Srivastava shall notify 010, in writing, of anyongoing investigation or legal proceeding known to Srivastava conducted orbrought by a governental entity or its agents involving an allegation thatSrivastava has committed a crime or has engaged in fraudulent activities. Thisnotification shall include a description of the allegation, the identity of theinvestigating or prosecuting agency, and the status of such investigation or legalproceeding. Srivastava shall also provide written notice to OIG within 30 daysafter the resolution ofthe matter, and shall provide 010 with a description of thefindings and/or results of the proceedings, if any.

H. Reporting

1.. Overpayments

a. Definition 0/ Overpayments. For purposes of this Agreement, an"Overpayment" shall mean the amount of money Srivastava has receivedin excess of the amount due and payable under any Federal health careprogram and FEHBP requirements.

b. Reporting a/Overpayments. If, at any time, Srivastava identifies orlearns of any Overpayment, Srivastava shall notify the payor ~,Medicare fiscal intermediary or. carrier) within 30 days after identificationof the Overpayment and take remedial steps within 60 days afteridentification (or such additional time as maybe agreed to by the payor) tocorrect the problem, including preventing the underlying problem and theOverpayment from recurring. Also, within 30 days after identification ofthe Overpayment, Srivastava shall repay the Overpayment to theappropriate payor to the extent such Overpayment has been quantified. Ifnot yet quantified within 30 days after identification, Srivastava shallnotify the payor at that time of its efforts to quantify the Overpaymentamount along with a schedule of when such work is expected to becompleted. Notification and repayment to the payor shall be done inaccordance with the payor's policies, and for Medicare contractors shallinclude the information contained on the Overpayment Refund Form,provided as Appendix C to this Agreement. Notwithstanding the above,notification and repayment of any Overpayment amount that routinely is

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reconciled or adjusted pursuant to policies and procedures established bythe payor should be handled in accordance with such policies andprocedures.

2. Reportable Events.

a. Definition o/Reportable Event. For purposes of this Agreement, a"Reportable Event" means anything that involves:

i. a substantial Overpayment; or

ii. a matter that a reasonable person would consider a probableviolation of criminal, civil, or administrative laws applicable. to anyFederal health care program or FEHBP for which penalties orexclusion may be authorized.

A Reportable Event may be the result of an isolated event or a series ofoccurrences.

b. Reporting 0/ Reportable Event. If Srivastava determines (after areasonable opportunity to conduct an appropriate review or investigationof the allegations) through any means that there is a Reportable Event,

Srivastava shall notify 010, in writing, within 30 days after making thedetermination that the Reportable Event exists. The report to OIG shallinclude the following information:

i. If the Reportable Eventresults in an Overpayment, the report toOIO shall be made at the same time as the notification to the payorrequired in Section III.H.1, and shall include all of the informationon the Overpayment Refund Form, as well as:

(A) the payor's name, address, and contact person to whomthe Overpayment was sent; and

(B) the date ofthe check and identification number (orelectronic transaction number) by which the Overpaymentwas repaid/refunded;

ii. a complete description of the Reportable Event, including therelevant facts, persons involved, and legal and Federal health care

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program and FEHBP authorities implicated;

iii. a description of Srivastava's actions taken to correct theReportable Event; and

iv. any further steps Srivastava plans to take to address the

Reportable Event and prevent it from recurring.

I. Third Party Biling

1. Current Contract with Third Part Biler. If Srivastava presently contractswith a third part billing company to submit claims to the Federal health care

programs and FEHBP, Srivastava represents that he does not have an ownershipor control interest (as defined in 42 U.S.c. § 1320a-3(a)(3)) in the third partbiling company and is not employed by, and does not act as a consultant to, thethird part biling company. If Srivastava intends to obtain an ownership or

control interest (as defined in 42 U.S.C. § 1320a-3(a)(3)) in, or becomeemployed by, or become a consultant to, any third par biling company duringthe term of this Agreement, Srivastava shall notify 01G 30 days prior to any suchproposed involvement.

Within 90 days after the Effective Date, Srivastava shall obtain (and provide toOIO in the Implementation Report) a certification from the third part bilingcompany that the company: (i) is presently in compliance with all Federal healthcare program and FEHBP requirements as they relate to the submission of claimsto Federal health care programs and FEHBP; (ii) has a policy of not employingany person who is excluded, debarred, suspended or otherwise ineligible toparticipate in Medicare or other Federal health care programs or FEHBP toperform any duties related directly or indirectly to the preparation or submissionof claims to Federal health care programs and FEHBP; (Hi) provides the requiredtraining in accordance with Section IILD of the Agreement for those employeesinvolved in the preparation and submission of claims to Federal health careprograms and FEHBP.

If Srivastava contracts with a new third part billng company during the term ofthis Agreement, Srivastava shall, within 30 days of entering into such contract,obtain and send to OIG the certification described in this Section III..1.

2. Future Contract with Third Part Biler. If, at any time during the term of this

Agreement, Srivastava contracts with a third part biling company to submit

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claims to the Federal health care programs and FEHBP, at least 30 days prior toexecuting the contract, Srivastava shall submit a certification indicating whetherhe has an ownership or control interest (as defined in 42 U.S.C. § 1320a-3(a)(3)) in the third part biling company and whether he is employed by or actsas a consultant to the third part biling company.

Within 30 days after Srivastava contracts with the third part biling company,Srivastava shall obtain a certification from the third par biling company thatthe company: (i) is presently in compliance with all Federal health care programand FEHBP requirements as they relate to the submission of claims to Federalhealth care programs and FEHBP; (ii) has a policy of not employing any personwho is excluded, debarred, suspended or otherwise ineligible to participate inMedicare or other Federal health care programs or FEHBP to perform any dutiesrelated directly or indirectly to the preparation or submission of claims to Federalhealth care programs and FEHBP; and (Hi) provides the required training inaccordance with Section III.D for those employees involved in the preparationand submission of claims to Federal health care programs and FEHBP.

If Srivastava contracts with a new third part biling company during the term ofthis Agreement, Srivastava shall, within 30 days of entering into such contract,obtain and send to OIG the certification described in this Section III.I.2.

iv. NEW BUSINESS UNITS OR LOCATIONS

In the event that, after the Effective Date, Srivastava changes locations or sells, closes,purchases, or establishes a new business unit or location related to the furnishing ofitems or services that may be reimbursed by Federal health care programs and FEHBP,Srivastava shall notify OIG of this fact as soon as possible, but no later than 30 daysafter the date of change of location, sale, closure, purchase, or establishment. Thisnotification shall include the address of the new business unit or location, phonenumber, fax number, Medicare Provider number, provider identification number, and/orsupplier number, and the corresponding contractor's name and address that issued eachnumber. Each new business unit or location and all Covered Persons at each newbusiness unit or location shall be subject to the applicable requirements in thisAgreement.

Prior to Srivastava becoming an employee or contractor with another part related to thefurnishing of items or services that may be reimbursed by Federal health care programsand FEHBP, Srivastava shall notify that part of this Agreement. This notification shallinclude a copy of the Agreement, a statement indicating the remaining term of the

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Agreement, and a summary of Srivastava's obligations under the Agreement. Inaddition, Srivastava shall notify OIG of such relationship in his next Annual Report.

V. REPORTS

A. Implementation Report

Within 90 (ninety) days after the Effective Date, Srivastava shall submit a written reportto OIG summarizing the status of its implementation of the requirements of thisAgreement (Implementation Report). The Implementation Report shall, at a minimum,include:

, 1. the Compliance Contact's name, address, and phone number, a description ofany other job responsibilties performed by the Compliance Contact, and the datethe Compliance Contact was appointed;

2. a copy of the notice Srivastava posted in his offce as required by SectionIII.B, a description of where the notice is posted, and the date the notice wasposted;

3. a copy of the written Policies and Procedures required by Section III.C andthe date these Policies and Procedures were implemented and distributed;

4. a copy of all training materials used for the training session(s) required bySection IILD, a description of the training, including a summary of the topics

covered, the length of each session, and a schedule of when the trainingsession(s) were held;

5. the name and qualifications of the IRO(s), a summary/description of allengagements between Srivi;stava and the IRO, including, but not limited to, anyoutside financial audits, compliance program engagements, or reimbursementconsulting, and the proposed start and completion dates of the first annualClaims Review.

6. a copy of the IRO's engagement letter, including the length of theengagement;

7. a certification from the IRO regarding its professional independence and/orobjectivity with respect to Srivastava;

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8. a description of Srivastava's process to screen Screened Persons to determineif they are ineligible;

9. a summary of personnel actions (other than hiring) taken pursuant to SectionIILF, the name, title and responsibilities of any person who is determined tobe an Ineligible Person under Section IILF, and the actions taken in responseto the obligations set forth in Section IILF;

10. a copy of the c.ertification from the third part billng company required bySection III.;

11. a list of all Srivastava's locations (including locations and mailngaddresses), the corresponding name under which each location is doingbusiness, the corresponding phone numbers and fax numbers, each location'sMedicare Provider number(s), provider identification number(s), and/orsupplier number(s), and the name and address of each contractor to whichSrivastava currently submits claims;

12. if Srivastava became an employee or contractor with another part related tothe furnishing of items or services that may be reimbursed by Federal health careprograms or FEHBP, Srivastava shall inform 01G of the name, location,relationship, and his responsibilties with respect Srivastava's employment orcontract; .

13. a certification by the Compliance Contact that:

a. the written Policies and Procedures required by Section IILC have beendeveloped, are being implemented, and have been distributed to allCovered Persons; and that all Covered Persons n.ave executed the writtenPolicies and .Procedures certification in accordance with the timeframerequired by Section IILC;

b. all Covered Persons and Relevant Covered Persons have completed theapplicable training required by Section HI.D; and that all Covered Personsand Relevant Covered Persons have executed the applicable trainingcertification(s) in accordance with the timeframe required by SectionIII.D;

c. all Screened Persons that were hired or engaged since the execution ofthe Agreement were screened against the Exclusion Lists and asked to

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disclose if they are excluded, debarred, suspended, or are otherwiseconsidered an Ineligible Person, prior to entering into their relationshipwith Srivastava, as required by Section III.F; and

d. all Screened Persons of Srivastava were screened against the ExclusionLists within 30 days after the Effective Date, as required by Section III.Fand the date(s) of the screening.

14. a certification signed by Srivastava certifying (a) to the best of hisknowledge, except as otherwise described in the Implementation Report,Srivastava is in compliance with all of the requirements of this Agreement and

(b) Srivastava has reviewed the Implementation Report and has made areasonable inquiry regarding its content and believes that the information isaccurate and truthfuL.

B. Annual Reports

Srivastava shall submit to OIG Annual Reports with respect to the status of, andfindings regarding, Srivastava's compliance activities for each of the five ReportingPeriods (Annual Report).

Each Annual Report shall, at a minimum, include:

i. any change in the name, address, phone number, or job responsibilities ofSrivastava's Compliance Contact;

2. any changes to the posted notice and the reason for such changes;

3. a copy of any new compliance-related Policies and Procedures;

4. a summary of any changes or amendments to the written Policies andProcedures required by Section III.C and the reason(s) for such changes ~,change in contractor policies);

5. a copy of all training materials used for the training session(s) required bySection III.D (to the extent they have not already been provided as part of theImplementation Report); a description of the training, including a summary ofthe topics covered; the length of each session; and a schedule of when the .training session(s) was held;

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6. a complete copy of all reports prepared pursuant to the IRO's Claims Review,required by Section lILE (and, if applicable for the first Annual Report, a copy ofthe certification described in Section III.EA.b);

7. if applicable, a certification by Srivastava stating that he does not currentlyand has not submitted any cost reports to any Federal health care programs orFEHBP since this Agreement was executed;

8. Srivastava's response and corrective action p1an(s) related to any issues raisedor recommendations made by the IRO, as a result of the Review(s) performed

pursuant to Section III.E;

9. a summary/description of all engagements between Srivastava and the IRO,including, but not limited to, any outside financial audits, compliance programengagements, or reimbursement consulting, if different from what was submittedas part of the Implementation Report;

10. a certification from the IRO regarding its professional independence andobjectivity to Srivastava;

i 1. a description of Srivastava's process to screen Screened Persons todetermine if they are ineligible (to the extent it has changed from theImplementation Report);

12. a summary of personnel actions/other than hiring taken pursuant to SectionIII.F; the name, titles and responsibilities of any person who is determined to bean Ineligible Person under Section IILF; and Srivastava's actions taken inresponse to the obligations set forth in Section III.F;

13. a summary describing any ongoing investigation or legal proceedingrequired to have been reported pursuant to Section IILO. The summary shallinclude a description of the allegation, the identity of the investigating orprosecuting agency, and the status of such investigation or legal proceeding;

14. a summary of Reportable Events (as defined in Section lII.H) identifiedduring the Reporting Period and the status of any corrective and preventativeaction relating to all such Reportable Events;

15. a report of the aggregate Overpayments that have been returned to theFederal health care programs and FEHBP. Overpayment amounts shall be

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broken down into the following categories: Medicare, Medicaid, other Federalhealth care programs, and FEHBP;

16. a copy of the certification from the third part biling company required bySection IILI, if applicable;

17. a description of all changes to the most recently provided list of Srivastava'slocations (including addresses) as required by Section iV. Include thecorresponding phone numbers, fax numbers, each location's Medicare ProviderNumber(s), provider identification number(s), and/or supplier number(s), and thename and address of the contractor that issued each number;

18. if Srivastava became an employee or contractor with another part related tothe furnishing of items or services that may be reimbursed by Federal health careprograms and FEHBP, Srivastava shall inform OIG of the name, location,relationship, and his responsibilities with respect Srivastava's employment orcontract;

19. copies of any revisions to the policies, procedures and guidelines developedby the ICO pursuant to section III.C;

20. Srivastava's response/corrective action plan to any issues raised by the ICO;

21. a certification by the ICO that Srivastava did not participate in or interferewith the development of any revisions to the policies, procedures, and guidelinesrequired by section III.C, and that Srivastava has cooperated fully with the ICOin implementing these policies, procedures, and guidelines.

22. a certification, where appropriate, by the Compliance Contact that certifiesthat:

a. the written Policies and Procedures have been reviewed during theReporting Period, as required by Section III.C, and that all CoveredPersons have executed the written Policies and Procedures certification inaccordance with the time frame required by Section III.C;

b. all Covered Persons and Relevant Covered Persons have completed theapplicable training required by Section III.D and that all Covered Personsand Relevant Covered Persons have executed the applicable trainingcertification(s) in accordance with the timeframe required by Section

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III.D;

c. all Screened Persons have been screened against the Exclusion Listsand asked to disclose if they are excluded, debarred, suspended, or areotherwise considered an Ineligible Person, prior to entering into theirrelationship with Srivastava, as required by Section III.F;

d. all Screened Persons were screened against the Exclusion Lists during

the Reporting Period, in accordance with Section III.F and the date(s) theywere screened;

e. (include in certification if Settlement Agreement included anUnallowable Cost provision) Srivastava has complied with its obligationsunder the Settlement Agreement: (i) not to resubmit to any Federal healthcare program and FEHBP payors any previously denied claims related tothe Covered Conduct addressed in the Settlement Agreement, and not toappeal any such denials of claims; (ii) not to charge to or otherwise seekpayment from Federal or State payors for unallowable costs (as defined inthe Settlement Agreement); and (iii) to identify and adjust any pastcharges or claims for unallowable costs.

22. a certification signed by Srivastava certifying that (a) to the best of hisknowledge, except as otherwise described in the applicable Report, Srivastava isin compliance with all of the requirements of this Agreement and (b) Srivastavahas reviewed the Annual Report and has made a reasonable inquiry regarding itscontent and believes that the information is accurate and truthfuL.

The first Annual Report shall be received by OIG no later than 60 days after the end ofthe first Reporting Period. Subsequent Annual Reports shall be received by OIG nolater than the anniversary date of the due date of the first Annual Report.

C. Designation of Information

Srivastava shall clearly identify any portions of its submissions that he believesare trade secrets, or information that is commercial or financial and privileged orconfidential, and therefore potentially exempt from disclosure under the FreedomofInformation Act (FOIA), 5 U.S.C. § 552. Srivastava shall refrain fromidentifying any information as exempt from disclosure if that information doesnot meet the criteria for exemption from disclosure under FOIA.

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Vi. NOTIFICATIONS AND SUBMISSION OF REpORTS

Unless otherwise stated in writing after the Effective Date, all notifications and Reportsrequired under this Agreement shall be submitted to the following entities:

OIG: Administrative and Civil Remedies BranchOffce of Counsel to the Inspector GeneralOffce ofInspector General

U.S. Department of Health and Human ServicesCohen Building, Room 5527330 Independence Avenue, SWWashington, DC 20201Telephone: (202) 619-2078

Facsimile: (202) 205-060

Srivastava: (Compliance Contact)

(Address)(City, State Zip)(Telephone:)(Facsimile: )

Unless otherwise specified, all notifications and Reports required by this Agreementshall be made by certified mail, overnight mail, hand delivery, or other means, providedthat there is proof that such notification was received. For purposes of this requirement,internal facsimile confirmation sheets do not constitute proof of receipt.

VII. OIG INSPECTION. AUDIT. AND REVIEW RIGHTS

In addition to any other rights 01G may have by statute, regulation, or contract, OIG or.its duly authorized representative(s) may examine or request copies of Srivastava'sbooks, records, and other documents and supporting materials and/or conduct on-sitereviews of any of Srivastava's locations for the purpose of verifying and evaluating: (a)Srivastava~s compliance with the terms ofthis Agreement; and (b) Srivastava~scompliance with the requirements of the Federal health care programs and FEHBP inwhich he participates. The documentation described above shall be made available bySrivastava to OIG or its duly authorized representative(s) at all reasonable times forinspection, audit, or reproduction. Furthermore, for purposes of this provision, OIG or

its duly authorized representative(s) may interview any of Srivastava~s employees,contractors, or agents who consent to be interviewed at the individual's place ofbusiness during normal business hours or at such other place and time as may be

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mutually agreed upon between the individual and OIG. Srivastava shall assist OIG orits duly authorized representative(s) in contacting and arranging interviews with suchindividuals upon OIG's request. Srivastava's employees may elect to be interviewedwith or without a representative of Srivastava present.

VIII. DOCUMENT AND RECORD RETENTION

Srivastava shall maintain for inspection all documents and records relating toreimbursement from the Federal health care programs and FEHBP, or to compliancewith this Agreement, for six years (or longer if otherwise required by law).

ix. DISCLOSURES

Consistent with HHS's FOIA procedures, set fort in 45 C.F.R. Part 5, OIO shall makea reasonable effort to notify Srivastava prior to any release by OIG of informationsubmitted by Srivastava pursuant to its obligations under this Agreement and identifiedupon submission by Srivastava as trade secrets, or information that is commercial orfinancial and privileged or confidential, under the FOIA rules. With respect to suchreleases, Srivastava shall have the rights set forth at 45 C.F .R. § 5 .65( d).

X. BREACH AND DEFAULT PROVISIONS

Srivastava is expected to fully and timely comply with all of its Agreement obligations.

A. Stipulated Penalties for Failure to Comply with Certain Obligations

As a contractual remedy, Srivastava and OIG hereby agree that failure to complywith certain obligations set forth in this Agreement (unless a timely writtenrequest for an extension has been requested and approved in accordance withSection B below) may lead to the imposition ofthe following monetary penalties(hereinafter referred to as "Stipulated Penalties") in accordance with thefollowing provisions.

1. A Stipulated Penalty of $750 (which shall begin to accrue on the day after thedate the obligation became due) for each day Srivastava fails to:

a. have a Compliance Contact in accordance with the requirements ofSection III.A;

b. establish and/or post a notice in accordance with the requirements of

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Section III.B;

c. establish, implement, maintain, distribute, and/or update the writtenPolicies and Procedures in accordance with the requirements of SectionIII. C ;

d. establish and implement a training program in accordance with therequirements öf Section IIID.

e. obtain a certification from the third par biler, send the third part biler

certification to OIG in accordance with the requirements of Section III., ornotify OIO within 30 days prior to Srivastava obtaining an ownership orcontrol interest (as defined in 42 U.S.C. § 1320a-3(a)(3)) in, or becomingemployed by, or becoming a consultant to, any third part biling company;

f. engage an IRO in accordance with the requirements of Section III.E.1.aand Appendix A;

g. submit the IRO's annual Claims Review Report in accordance with therequirements of Section III.E and Appendix B;

h. obtain and/or maintain the following documentation: Policies andProcedures certifications in accordance with the requirements of SectionIII.C, training certification(s) in accordance with the requirements ofSection III.D, and/or documentation of screening and disclosurerequirements in accordance with the requirements of Section III.F .2.

i. screen Screened Persons in accordance with the requirements of Section

III.F; or require Screened Persons to disclose if they are debarred, excluded,suspended or are otherwise considered an Ineligible Person in accordancewith the requirements of Section III.F;

j. notify OIG ofa Oovemment investigation or legal proceeding, inaccordance with the requirements of Section III.G; or

k. retain the ICO in accordance with Section III.C.

2. A Stipulated Penalty of $1 ,000 (which shall begin to accrue on the day afterthe date the obligation became due) for each day Srivastava fails to submit theImplementation Report or the Annual Reports to GIG in accordance with the

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requirements of Section. V by the deadlines for submission.

3. A Stipulated Penalty of $750 for each day Srivastava fails to grant access tothe information or documentation as required in Section VII. (This StipulatedPenalty shall begin to accrue on the date Srivastava fails to grant acèess.)

4. A Stipulated Penalty of $15,000 for each false certification submitted by or onbehalf of Srivastava as part of its Implementation Report, Annual Reports,additional documentation to a Report (as requested by OIG), or as otherwiserequired by this Agreement.

5. A Stipulated Penalty of$750 for each day Srivastava fails to comply fully andadequately with any obligation of this Agreement. OIG shall provide notice

(Notice) to Srivastava stating the specific grounds for its determination thatSrivastava has failed to comply fully and adequately with the Agreementobligation(s) at issue and steps the Srivastava shall take to comply with theAgreement. (This Stipulated Penalty shall begin to accrue 10 days after the dateSrivastava receives this Notice from 01G of the failure to comply.) A Stipulated.Penalty as described in this Subsection shall not be demanded for any violationfor which OIO has sought a Stipulated Penalty under Subsections 1-4 of thisSection.

6. A Stipulated Penalty of $2,500 (which shall begin to accrue ten (10) daysafter the date OIG provides notice to Srivastava of the failure to comply) for eachday Srivastava fails to comply fully and adequately with any of his obligationswith respect to the ICO, as set forth in section III.C. In its notice to Srivastava,the OIO shall state the specific grounds for its determination that Srivastava hasfailed to comply fully and adequately with the CIA ob1igation(s) at issue.

B. Timely Written Requests for Extensions

Srivastava may, in advance of the due date, submit a timely written request for anextension of time to perform any act or fie any notification or Report required bythis Agreement. Notwithstanding any other provision in this Section, ifOIGgrants the timely written request with respect to an act, notification, or Report,Stipulated Penalties for failure to perform the act or fie the notification orReport shall not begin to accrue until one day after Srivastava fails to meet therevised deadline set by OIG. Notwithstanding any other provision in thisSection, if OIG denies such a timely written request, Stipulated Penalties forfailure to perform the act or fie the notification or Report shall not begin to

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accrue until three business days after Srivastava receives OIG's written denial ofsuch request or the origInal due date, whichever is later. A "timely writtenrequest" is defined as a request in writing received by OIO at least five businessdays prior to the date by which any act is due to be performed or any notificationor report is due to be filed.

c. Payment of Stipulated Penalties.

1. Demand Letter. Upon a finding that Srivastava has failed to comply with anyof the obligations described in Section X.A and after determining that StipulatedPenalties are appropriate, OIG shall notify Srivastava of: (a) Srivastava's failureto comply; and (b) OIG's exercise of its contractual right to demand payment ofthe Stipulated Penalties (this notification is referred to as the "Demand Letter").

2. Response to Demand Letter. Within 10 days of the receipt of the Demand

Letter, Srivastava shall either: (a) cure the breach to OIG's satisfaction and paythe applicable Stipulated Penalties; or (b) send in writing to 010 a request for ahearing before an HHS administrative law judge (ALJ) to dispute OIO'sdetermination of noncompliance, pursuant to the agreed upon provisions set forthbelow in Section X.E. In the event Srivastava elects to request. an ALl hearing,the Stipulated Penalties shall contInue to accrue until Srivastava cures, to OIG'ssatisfaction, the alleged breach in dispute. Failure to respond to the DemandLetter in one of these two manners within the allowed time period shall beconsidered a material breach of this Agreement and shall be grounds forexclusion under Section X.D.

3. Form of Payment. Payment of the Stipulated Penalties shall be made bycertified or cashier's check, payable to: "Secretary of the Department of Healthand Human Services," and submitted to OIG at the address set forth in SectionVI.

4. Independence from Material Breach Determination. Except as set forth inSection X.D.l.c, these provisions for payment of Stipulated Penalties shall notaffect or otherwise set a standard for OIG's decision that Srivastava hasmaterially breached this Agreement, which decision shall be made at OIG'sdiscretion and shall be governed by the provisions in Section XD, below.

D. Exclusion for Material Breach of this Agreement

1. Definition of Material Breach. A material breach of this Agreement means:

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a. a failure by Srivastava to report a Reportable Event, take correctiveaction and make the appropriate refunds, as required in Section IlI.H;

b. a repeated or flagrant violation of the obligations under thisAgreement, including, but not limited to, the obligations addressed inSection X.A;

c. a failure to respond to a Demand Letter concerning the payment ofStipulated Penalties in accordance with Section X.C;

d. a failure to engage and use an IRO in accordance with Section lII.E; or

e. a failure to engage and use an ICO in accordance with Section III.C.

2. Notice of Material Breach and Intent to Exclude. The parties agree that amaterial breach of this Agreement by Srivastava constitutes an independent basisfor Srivastava's exclusion from participation in the Federal health care programsand FEHBP. Upon a determination by OIG that Srivastava has materiallybreached this Agreement and that exclusion is the appropriate remedy, OIG shallnotify Srivastava of: (a) Srivastava's material breach; and (b) OIO's intent toexercise its contractual right to impose exclusion (this notification is hereinafterreferred to as the "Notice of Material Breach and Intent to Exclude").

3. Opportunity to Cure. Srivastava shall have 30 days from the date of receipt ofthe Notice of Material Breach and Intent to Exclude to demonstrate to OIG'ssatisfaction that:

a. Srivastava is in compliance with the obligations of the Agreement citedby OIG as being the basis for the material breach;

b. the alleged material breach has been cured; or

c. the alleged material breach cannot be cured within the 30-day period, but

that: (i) Srivastava has begun to take action to cure the material breach; (ii)Srivastava is pursuing such action with due dilgence; and (iii) Srivastavahas provided to OIG a reasonable timetable for curing the material breach.

4. Exclusion Letter. If at the conclusion of the 30-day period, Srivastava fails tosatisfy the requirements of Section X.D.3, 010 may exclude Srivastava from

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participation in the Federal health care programs and FEHBP.OIG shall notifySrivastava in writing of its determination to exclude Srivastava (this letter shallbe referred to hereinafter as the "Exclusion Letter"). Subject to the DisputeResolution provisions in Section X.E, below, the exclusion shall go into effect 30days after the date of Srivastava's receipt of the Exclusion Letter. The exclusion

shall have national effect and shall also apply to all other Federal procurementand nonprocurement programs. Reinstatement to program participation is notautomatic. After the end of the period of exclusion, Srivastava may apply forreinstatement, by submitting a written request for reinstatement in accordancewith the provisions at 42 C.F.R. §§ 1001.3001-.3004.

E. Dispute Resolution

1. Review Rights. Upon 01G's delivery to Srivastava of its Demand Letter or ofits Exclusion Letter, and as an agreed-upon contractual remedy for the resolutionof disputes arising under this Agreement, Srivastava shall be afforded certainreview rights comparable to the ones that are provided in 42 U.S.C. § 1320a-7(f)and 42 C.F.R. Part 1005 as if they applied to the Stipulated Penalties orexclusion sought pursuantto this Agreement. Specifically, OIG's determinationto demand payment of Stipulated Penalties or to seek exclusion shall be subjectto review by an HHS ALJ and, in the event of an appeal, the HHS DepartmentalAppeals Board (DAB), in a manner consistent with the provisions in 42 C.F.R. §1005.2-1005.21. Notwithstanding the language in 42 C.F.R. § io05.2(c), therequest for a hearing involving Stipulated Penalties shall be made within 10 daysafter the "receipt of the Demand Letter and the request for a hearing involvingexclusion shall be made within 25 days after receipt of the Exclusion Letter.

2. Stipulated Penalties Review. Notwithstanding any provision of Title 42 ofthe United States Code or Chapter 42 of the Code of Federal Regulations, theonly issues in a proceeding for Stipulated Penalties under this Agreement shallbe: (a) whether Srivastava was in full and timely compliance with theobligations of this Agreement for which 010 demands payment; and (b) theperiod of noncompliance. Srivastava shall have the burden of proving its fulland timely compliance and the steps taken to cure the noncompliance, if any.OIG shall not have the right to appeal to the DAB an adverse ALJ decisionrelated to Stipulated Penalties. If the ALJ agrees with 010 with regard to afinding of a breach of this Agreement and orders Srivastava to pay StipulatedPenalties, such Stipulated Penalties shall become due and payable 20 days afterthe ALJ issues such a decision unless Srivastava requests review of the ALJdecision by the DAB. If the ALJ decision is properly appealed to the DAB and

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the DAB upholds the determination ofOIG, the Stipulated Penalties shallbecome due and payåb1e 20 days after the DAB issues its decision.

3. Exclusion Review. Notwithstanding any provision of Title 42 of the UnitedStates Code or Chapter 42 of the Code of Federal Regulations, the only issues ina proceeding for exclusion based on a material breach of this Agreement shallbe:

a. whether Srivastava was in material breach of this Agreement;

b. whether such breach was continuing on the date of the ExclusionLetter; and

c. whether the alleged material breach could not have been cured withinthe 30 day period, but that: i. Srivastava had begun to take action to cure

the material breach within that period; ii. Srivastava has pursued and ispursuing such action with due diligence; and iii. Srivastava provided toOIG within that period a reasonable timetable for curing the materialbreach and Srivastava has followed the timetable.

F or purposes of the exclusion herein, exclusion shall take effect only after anALl decision favorable to OIG, or, if the ALl rules for Srivastava, only after aDAB decision in favor ofOIG. Srivastava's election of its contractual right to"appeal to the DAB shall not abrogate OIG's authority to exclude Srivastava uponthe issuance of an ALl's decision in favor of 010. If the ALl sustains thedetermination ofOIO and determines that exclusion is authorized, suchexclusion shall take" effect 20 days after theALl issues such a decision,notwithstanding that Srivastava may request review of the ALl decision by theDAB. If the DAB finds in favor of OIO after an ALl decision adverse to OIG,the exclusion shall take effect 20 days after the DAB decision. Srivastava shallwaive his right to any notice of such exclusion if a decision upholding theexclusion is rendered by the ALlor DAB. If the DAB finds in favor ofSrivastava, Srivastava shall be reinstated effective on the date of the originalexclusion.

4. Finality of Decision. The review by an ALlor DAB provided for above shallnot be considered to be an appeal right arising under any statutes or regulations.Consequently, the parties to this Agreement agree that the DAB's decision (orthe ALl's decision ifnot appealed) shall be considered final for all purposesunder this Agreement.

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XI. EFFECTIVE AND BINDING AGREEMENT

Consistent with the provisions in the Settlement Agreement pursuant to which thisAgreement is entered, and into which this Agreement is incorporated, Srivastava andOIG agree as follows:

A. This Agreement shall be binding on the successors, assigns, and transfereesof Srivastava;

B. This Agreement shall become final and binding on the date the final signatureis obtained on the Agreement;

C. Any modifications to this Agreement shall be made with the prior writtenconsent of the parties to this Agreement;

D. OIG may agree to a suspension of Srivastava's obligations under thisAgreement in the event of Srivastava's cessation of paricipation in Federalhealth care programs and FEHBP. If Srivastava withdraws from participation inFederal health care programs and FEHBP and is relieved of his Agreementobligations by 010, Srivastava shall notify OIG 30 days in advance ofSrivastava's intent to reapply as a participating provider or supplier with anyFederal health care program or FEHBP. Upon receipt of such notification, OIGshall evaluate whether the Agreement shall be reactivated or modified.

E. All requirements and remedies set forth in this Agreement are in addition to,and do not effect, (1) Srivastava's responsibilty to follow all applicable Federalhealth care program and FEHBP requirements or (2) the Government's right toimpose appropriate remedies for failure to follow applicable programrequirements.

F. The undersigned Srivastava signatory(ies) represent(s) and warrant(s) that

(he, she or they) are authorized to execute this Agreement. The undersigned OIGsignatory represents that he is signing this Agreement in his offcial capacity andthat he is authorized to execute this Agreement.

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IN WITNSS WHEREOF, the parties hereto affx their signatures:

. Î (i +t;)Date

0tr.ô~David O'BrienCrowell & Moringi 00 1 Pennsylvania Ave. NWWashington, DC 20004Counsel for Srivastava

V()).( ¿)~, cko7Date /

OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMANSERVICES

Greg1~ ~ lgr¡?Date

Assistant Inspector Oeneral for Legal AffairsOffce of Counsel to the Inspector OeneralOffce of Inspector GeneralU. S. Department of Health and Human Services

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APPENDIX AINDEPENDENT REVIEW ORGANIZATION

This Appendix contains the requirements relating to the Independent ReviewOrganization (IRO) required by Section IILE of the CIA.

A. IRO Engagement.

Srivastava shall engage an IRO that possesses the qualifications set forth inParagraph B, below, to perform the responsibilities in Paragraph C, below. The IROshall conduct the reviews in a professionally independent and/or objective fashion, as setforth in Paragraph D. Within 30 days after 010 receives written notice of the identity ofthe selected IRO, OIG wil notify Srivastava if the IRO is unacceptable. Absentnotification from OIG that the IRO is unacceptable, Srivastava may continue to engagethe IRO.

If Srivastava engages a new IRO during the term of the CIA, this IRO shall alsomeet the requirements of this Appendix. If a new IRO is engaged, Srivastava shallsubmit the information identified in Section V.A.S to OIG within 30 days of engagementof the IRO. Within 30 days after OIG receives written notice of the identity of theselected IRO, OIG wil notify Srivastava if the IRO is unacceptable. Absent notificationfrom OIG that the IRO is unacceptable, Srivastava may continue to engage the' IRO.

B. IRO Qualifications.

The IRO shall:

i. assign individuals to conduct the Claims Review engagement who haveexpertise in the biling, coding, reporting, and other requirements of billng for cardiology

items and services and in the general requirements of the Federal health care program(s)and FEHBP from which Srivastava seeks reimbursement;

2. assign individuals to conduct the Cardiac Procedures Review engagement whohave expertise in the medical necessity and appropriateness of interventional cardiacprocedures, the established practice guidelines and generally accepted standards ofmedical practice described by the American College of Cardiology, and the generalrequirements of the Federal health care program(s) and FEHBP from which Srivastavaseeks reimbursement;

3. assign individuals to design and select the Claims Review and CardiacProcedures Review samples who are knowledgeable about the appropriate statisticalsampling techniques;

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3. assign individuals to conduct the coding review portions of the Claims Reviewwho have a nationally recognized coding certification (~, CCA, CCS, CCS-P, CPC,RR, etc.) and who have maintained this certification (~, completed applicablecontinuing education requirements); and

4. have suffcient staff and resources to conduct the reviews required by the CIA

on a timely basis.

C. IRO Responsibilties.

The lRO shall:

l. perform each Claim Review and Cardiac Procedures Review in accordance

with the specific requirements ofthe CIA;

2. follow all applicable Medicare and FEHBP rules and reimbursement guidelinesin making assessments in the Claims Review and Cardiac Procedures Review;

3. if in doubt of the application of a partcular Medicare or FEHBP policy orregulation, request clarification from the appropriate authority (~, fiscal intermediary orcarrier);

4. respond to all OIG inquires in a prompt, objective, and factual manner; and

5. prepare timely, clear, well-written reports that include all the informationrequired by Appendix B.

D. IRO Independence/Obiectivity.

The IRO must perform the Claims Review in a professionally independent and objectivefashion, as appropriate to the nature of the engagement, taking into account any otherbusiness relationships or engagements that may exist between the lRO and Srivastava.

E. IRO Removal/Termination.

1. Provider. If Srivastava terminates the IRO during the course of the

engagement, Srivastava must submit a notice explaining its reasons to 01G no later than30 days after termination. Srivastava must engage a new IRO in accordance withParagraph A of this Appendix.

2. OIG Removal of IRO. In the event OIG has reason to believe that the IRO doesnot possess the qualifications described in Paragraph B, is not independent and/orobjective as set forth in Paragraph D, or has failed to carr out its responsibilities as

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described in Paragraph C, OIO may, at its sole discretion, require Srivastava to engage anew IRO in accordance with Paragraph A of this Appendix.

Prior to requiring Srivastava to engage a new IRO, OIG shall notify Srivastava ofits intent to do so and provide a written explanation of why OIO believes such a step isnecessary. To resolve any concerns raised by OIG, Srivastava may request a meetingwith 01G to discuss any aspect of the IRO's qualifications, independence or performanceof its responsibilities and to present additional information regarding these matters.Srivastava shall provide any additional information as may be requested by 01G underthis Paragraph in an expedited manner. OIG wil attempt in good faith to resolve anydifferences regarding the IRO with Srivastava prior to requiring Srivastava to terminatethe IRO. However, the final determination as to whether or not to require Srivastava toengage a new IRO shall be made at the sole discretion ofOIG.

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APPENDIX BCLAIMS AND CARDIAC PROCEDURES REVIEWS

A. Claims Review.

1. Definitons. For the purposes of the Claims Review, the following definitions

shall be used:

a. Overpayment: The amount of money Srivastava has received in excess ofthe amount due and payable under any Federal health care programrequirements.

b. Item: Any discrete unit that can be sampled (~, code, line item,beneficiary, patient encounter, etc.).

c. Paid Claim: A code or line item submitted by Srivastava and for whichSrivastava has received reimbursement from the Medicare or FEHBP program.

d. Population: For the first Reporting Period, the Population shall be definedas all Items for which a code or line item has been submitted by or on behalf ofSrivastava and for which Srivastava has received reimbursement fromMedicare or FEHBP (i.e., Paid Claim) during the 12-month period covered bythe first Claims Review.

F or the remaining Reporting Periods, the Population shall.be defined .as allItems for which Srivastava has received reimbursement from Medicare orFEHBP (i.e., Paid Claim) during the 12-month period covered by the ClaimsReview.

To be included in the Population, an Item must have resulted in at least onePaid Claim.

e. Error Rate: The Error Rate shall be the percentage of net Overpaymentsidentified in the sample. The net Overpayments shall be calculated bysubtracting all underpayments identified in the sample from all grossOverpayments identified in the sample. (Note: Any potential cost settlementsor other supplemental payments should not be included in the net Overpayment.calcu1ation. Rather, only underpayments identified as part of the DiscoverySample shall be included as part of the net Overpayment calculation.)

The Error Rate is calculated by dividing the net Overpayment identified in thesample by the total dollar amount associated with the Items in the sample.

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2. Other Requirements.

a. Paid Claims without Supporting Documentation. For the purpose ofappraising Items included in the Claims Review, any Paid Claim for whichSrivastava cannot produce documentation sufficient to support the PaidClaim shall be considered an error and the total reimbursement received bySrivastava for such Paid Claim shall be deemed an Overpayment.Replacement sampling for Paid Claims with missing documentation is notpermitted.

b. Replacement Sampling. Considering the Population shall consist onlyof Paid Claims and that Items with missing documentation cannot bereplaced, there is no need to utilize alternate or replacement sampling units.

c. Use of First Samples Drawn. For the purposes of all samples (DiscoverySample(s) and Full Samp1e(s)) discussed in this Appendix, the Paid Claimsassociated with the Items selected in each first sample (or first sample foreach strata, if applicable) shall be used (i.e., it is not permissible to generatemore than one list of random samples and then select one for use with theDiscovery Sample or Full Sample).

B. Cardiac Procedures Review. .

1. Definitions. For purposes of the Cardiac Procedures Review, the followingdefinitions shall be used:

a. Interventional Cardiac Procedure: Any percutanaeous coronaryinterventions, including but not limited to, percutaneous transluminalcoronary angioplasties, balloon angioplasties, and implantation ofintracoronary stenting, and any cardiac catheterization.

b. Population: For each Reporting Period, the Population shall be definedas all Interventiona1 cardiac Procedures for which Srivastava has receivedreimbursement form Medicare or FEHBP. During the relevant 12-monthReporting Period.

2. Other Requirements.

a. Interventional Cardiac Procedures without Supporting Documentation.

For the purpose of reviewing Interventiona1 Cardiac Procedures, anyInterventiona1.Cardiac Procedure for which Srivastava cannot producedocumentation suffcient to support the medical necessity orappropriateness of the Interventional Cardiac Procedure shall be

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considered an error. Replacement sampling for Interventional CardiacProcedures with missing documentation is not permitted.

b. Replacement Sampling. Considering the Populations shall consist onlyof Interventional Cardiac Procedures and that Interventiona1 CardiacProcedures with missing documentation cannot be replaced, there is noneed to utilze alternate or replacement sampling units.

c. Use of First Samples Drawn. For purposes ofthe Sample, theInterventional Cardiac Procedures selected in each first sample (or firstsample for each strata, if applicable) shall be used (i.e., it is notpermissible to generate more than one list of random samples and thenselect one to be used.)

C. Claims Review and Cardiac Procedures Review Reports. The following

information shall be included in the Claims Review and Cardiac Procedures ReviewReports for each Discovery Sample and Full Sample (if applicable).

1. Claims Revie-l and Cardiac Procedures Review Methodology.

ii. Sampling Unit. A description of the Item as that term is utilized for theClaims Review and Cardiac Procedures Review.

b. Claims Review and Cardiac Procedures Review Population. A

description of the Population subject to the Claims Review and CardiacProcedures Review.

c. Claims Review and Cardiac Procedures Review Obíective. A clearstatement of the objective intended to be achieved by the Claims Reviewand Cardiac Procedures Review.

d. Sampling Frame. A description of the sampling frame, which is thetotality of Items from which the Discovery Sample and, if any, Full Samplehas been selected and an explanation of the methodology used to identifythe sampling frame. In most circumstances, the sampling frame wil beidentical to the Population.

e. Source of Data. A description of the specific documentation relied uponby the IRO when performing the Claims Review and Cardiac ProceduresReview (~, medical records, physician orders, certificates of medicalnecessity, requisition forms, local medical review policies (including titleand policy number), CMS program memoranda (including title and

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issuance number), Medicare carrier or intermediar manual or bulletins(including issue and date), other policies, regulations, or directives).

f. Review Protocol. A narative description of how the Claims Review andCardiac Procedures Review were conducted and what was evaluated.

2. Statistical Sampling Documentation.

a. The number of Items appraised in the Discovery Sample and, ifapplicable, in the Full Sample.

b. A copy ofthe printout of the random numbers generated by the"Random Numbers" function of the statistical sampling softare used bythe IRO.

c. A copy of the statistical softare printout(s) estimating how many Itemsare to be included in the Full Sample, if applicable.

d. A description or identification of the statistical sampling softarepackage used to select the sample and determine the Full Sample size, ifapplicable.

3. Claims Review Findings.

a. Narrative Results.

i. A description of Srivastava's biling and coding system(s),including the identification, by position description, of the personnelinvolved in coding and biling.

ii. A narrative explanation of the IRO's findings and supportingrationale (including reasons for errors, patterns noted, etc.) regardingthe Claims Review, including the results of the Discovery Sample,and the results of the Full Sample (if any).

b. Quantitative Results.

i. Total number and percentage of instances in which the IROdetermined that the Paid Claims submitted by Srivastava (ClaimSubmitted) differed from what should have been the correct claim(Correct Claim), regardless of

the effect on the payment.

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ii. Total number and percentage of instances in which the ClaimSubmitted differed from the Correct Claim and in which suchdifference resulted in an Overpayment to Srivastava.

11. Total dollar amount of all Overpayments in the sample.

iv. Total dollar amount of paid Items included in the sample and thenet Overpayment associated with the sample.

v. Error Rate in the sample.

vi. A spreadsheet of the Claims Review results that includes thefollowing information for each Paid Claim appraised: Federal healthcare program or FEHBP biled, beneficiary health insurance claimnumber, date of service, procedure code submitted, procedure codereimbursed, allowed amount reimbursed by payor, correct procedurecode (as determined by the IRO), correct allowed amount (asdetermined by the IRO), dollar difference between allowed amountreimbursed by payor and the correct allowed amount. (SeeAttachment i to this Appendix.)

4. Cardiac Procedures Review Findings.

a. A narrative explanation of the IRO's findings and supporting rationale(including reasons for errors, patterns noted, etc.) regarding the CardiacProcedures Review, including the results of the Sample.

b. Total number of instances in which the IRO determined that theInterventional Cardiac Procedure was not medically necessary orappropriate, based on established practice guidelines and generally acceptedstandards of medical practice as described by the American College ofCardiology.

c. A spreadsheet of the Cardiac Procedures Review results that includes thefollowing information for each Interventiona1 Cardiac Procedureperformed, whether the Interventiona1 Cardiac Procedure was ,medicallynecessary and appropriate, beneficiary' name, beneficiary health insuranceclaims number, date of service, procedure code submitted, Federal healthcare program or FEHBP biled, and amount reimbursed.

5. Systems Review. . Observations, findings, and recommendations on possibleimprovements to the system(s) and process(es) that generated the Overpayment(s).

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6. Credentials. The names and credentials of the individuals who: (1) designedthe statistical sampling procedures and the review methodology utilzed for the ClaimsReview and Cardiac Procedures Review; and (2) performed the Claims Review and

Cardiac Procedures Review.

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. APPENDIX C

OVERPAYMENT REFUND

TO BE COMPLETED BY MEDICARE CONTRACTORDate:Contractor Deposit Control #

Contractor Contact Name:Contractor Address:

Contractor Fax:

Date of Deposit:Phone #

.

TO BE COMPLETED BY PROVIDERIHYSICIAN/SUPPLIERPlease complete and orwar to Me icare Contractor. T. is orm, or a simi ar ocument containing the followinginformation, should accompany every voluntary refund so t at receipt of check is properly recorded and applied.

PROVIDERJPHYSI CIANISUPPLIERNAMEADDRESSPROVIDER/PHYSICIAN/SUPPLIER #CONTACT PERSON:$ CHECK DATE

CHECK NUMBER#PHONE # AMOUNT OF CHECK

REFUND INFORMATION

For each Claim. provide the following::Patient Name Hie #Medicare Claim Number Claim Amount Refunded $Reason Code for Claim Adjustment:_ (Select reason code from list below. Use one reason per claim)

(Please list all claim numbers involved. Attach separate sheet, ifnecessary)

Note: If Specifc Patient/HIC/Claim #/ClaimAmount data not available for all claims due to Statistical Sampling,please indicate methodology and formula used to determine amount and reason foroverpayme nt:

For Institutional Facilties Only:Cost Report Y ear( s)(If multiple cost report years are involved, provide a breakdown by amount and corresponding cost report year.)For OIG Reporting Requirements:Do ou have a Co orate Inte ri A reement with OIG?

Reason Codes:Billing/Clerical Error01 - Corrected Date of Service02 - Duplicate03 - Corrected CPT Code04 - Not Our Patient(s)05 - Modifier Added/Removed06 - Billed in Error07 - Corrected CPT Code

Yes No

MSP/Other Payer Involvement08 - MSP Group Health Plan Insurance09 - MSP No Fault Insurance10 - MSP Liability .Insurance1 I - MSP, Workers Comp.(Including

Black Lung12 - Veterans Administration

Miscellaneous13 - Insuffcient Documentation14 - Patient Enrolled in an HMO15 - Services Not Rendered16 - Medical Necessity17 - Other (Please Specify)